BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU MEDICAL PRIMARY PLUM SET ORANGE PE LINED

    MDR report key: 15976550 · Received December 13, 2022

    Report

    Report Number
    MW5113756
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    December 8, 2022
    Report Date
    December 9, 2022
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TUBING MALFUNCTION - PRIMARY PLUM SET LIST #12339-12, LOT#: 5934274, EXP. 2025-06-01. PHARMACY HAD TO CHANGE THE TUBING LINE BEFORE CHEMOTHERAPY WAS STARTED. NURSE NOTICED TUBING ISSUE PRIOR TO HANGING CHEMOTHERAPY. PATIENT WAS DELAYED THERAPY FOR ABOUT 10 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407321 ICU MEDICAL PRIMARY PLUM SET ORANGE PE LINED SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. 5934274

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention